BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Stitch Cerclage – Suture Tapes

    K Number: K243905 · Decision Aug 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    13
    Review Days
    238

    Basic Information

    Device Name
    Stitch Cerclage – Suture Tapes
    K Number
    K243905
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GM Dos Reis Industria e Comercio Ltda.
    Date Received
    December 19, 2024
    Decision Date
    August 14, 2025
    Product Code
    JDQ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDQ Cerclage, Fixation

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